Medtronic recalls Abre Venous Self-expanding System due to incorrect size printed on device, packaging labeled correctly. Affected units may have size mismatch risks.
Incorrect size printed on the device; packaging is labeled correctly.
Medtronic is recalling its Abre Venous Self-expanding System because the device has the wrong size printed on it, while the packaging shows the correct size. This could lead to improper use if the wrong size is used during medical procedures.
The device has an incorrect size printed on it, which could lead to improper sizing during medical procedures. However, the packaging correctly labels the intended size, so the risk is limited to the device being used with the wrong size.
Healthcare professionals using the device for venous procedures may be affected. Patients receiving the device are not directly at risk from this labeling issue.
Check for the catalog number REF AB9U16080090 on the device packaging. The UDI is 00643169796348 and lot number B086915.
Verify the size printed on the device matches the packaging label.
The device is safe to use if the size printed on it matches the packaging label. If not, it should be checked with the manufacturer.
Look for the catalog number REF AB9U16080090 on the device packaging, with UDI 00643169796348 and lot number B086915.
No, but you should check the device size against the packaging label to ensure it's correct.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1532-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1532-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
